SOPs

SOP for Inventory Control of Materials and Components

ABHA

SOP for Inventory Control of Materials and Components

Objective

  • To lay down a procedure of Inventory Control of all the materials and components for the handling of receipt, storage, and disposal of all the Raw Materials, Packing Materials, and Finished Goods, Obsolete or Outdated / Returned / Rejected materials.

Scope

  • This Standard Operating Procedure is applicable in Stores for the personnel dealing with Raw Materials, Packing Materials, and Finished Goods for Inventory Control of Materials and Components.

Inventory Control

Responsibility

  • Concerned Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • The concerned Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

Concerned Store in-charge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP:            Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA:            Quality Assurance
  • Ltd.:            Limited
  • GMP:            Good Manufacturing Practices

Procedure

Procedure for Inventory Control of Materials and Components

  • The In-charge of Raw Material Store, Packing Material Store, and Finished Goods Store shall maintain proper records in respect to the Inventory Control of Materials and Components.

Inventory Control regarding Raw Materials:-The following records shall be maintained by the Incharge of the Raw Material Store in which necessary inventories shall be regularly made:

1. Raw Material Receipt Note:- The inventories of the following particulars shall be made in this record:

    1. R.M receipt No. / GRN No. and Date
    2. Invoice No. and Date
  • Name and address of the supplier
  1. Name and address of the transporter
  2. Gate entry date and vehicle No.
  3. Name of material and its Batch No,
  4. No. of containers and quantity in each
  5. Rate, Amount, and Tax
  6. Quantity in Invoice, Quantity received, and Shortage, if any.

2. Daily Receipt Record:- In this record, the following inventories shall be made:

  1. GRN No. and Date
  2. Vendor’s Name
  3. Name of an item and its Code No.
  4. Quantity Received

3. GRN intimation sent to QC Department:- Inventories of the following particulars shall be made in this intimation record:

  1. Item Name
  2. Supplier Name
  3. GRN No. and Date
  4. Invoice No. and Date
  5. Batch No. and Batch Quantity
  6. No. of containers
  7. Manufacturer
  8. Intimation date

NOTE: –  

  • The material on the receipt shall be stored in the quarantine area. The Quality Control after taking the sample of material shall label the containers with the status label of “Quarantine-Sampled” which shall be of Yellow color.
  • The Quality Control after testing shall put the status label of “Released” of green colour in case of results complies or “Rejected” of Red colour, in case of not results complies.
  • The Passed / released material shall be stored at proper storing condition in the approved Raw Material Store and the Rejected material shall be shifted to the Rejected Goods Store.
  1. Raw Material Issue Note :- The Incharge of Raw Material Store shall make the inventories of the following particulars in this record for the supply of materials to the Production Department on the basis of Requisition Slip produced by the Production Department:
  2. Name of the Department to whom issued
  3. Document / Issue No. and Date
  4. Requisition No. and Date
  5. Product to be manufactured, its Batch No., Batch Size, Mfg. date, Exp. Date and Unit Qty.
  6. Name of the material issued, Required Qty., Qty. issued, GRN No., Q.C. No. and Issued Qty.
  1. Stock Sheet :- In this record, inventories of the below noted particulars shall be made:
  2. Date
  3. Name of Raw Material and its Code No.
  • Opening balance, Batch No. and Mfg. Date
  1. Supplier’s Name and Address
  2. Manufacturer’s Name and Address
  3. Invoice No. and Dateof containers received
  4. Shortage, if any issued
  5. Name of product for which issued, its Batch No. and Batch Size
  • Closing balance
    • Inventory Control regarding Packing Materials :- The following records shall be maintained by the in-charge of the Packing Material Store in which necessary inventories shall be regularly made:
    • Packing Material receipt Note: – The inventories of following particulars shall be made in this record.
  1. GRN No. and Date
  2. Name of supplier
  • Invoice No. and Date in Invoice, Qty. received and difference
  1. Item Name, Qty. and No. of boxes
  2. Rate, Amount, Taxes and Freight charges
  3. Gate entry, Date and vehicle No.
  4. Transporter’s Name

GRN intimation sent to QC Department:- In this record, inventories of following particulars shall be made:

  1. Item Name
  2. Supplier Name
  3. GRN No. and Date
  4. Invoice No. and Date
  5. Batch No. and Batch Quantity of containers
  6. Manufacturer
  7. Intimation

  NOTE:-

  • The material on receipt shall be stored in the quarantine area. The Quality Control after taking the sample of material shall label the containers with status label of “Quarantine-Sampled” which shall be of yellow Colour.
  • The Quality Control after testing shall put status label of “Released” of green colour in case of results complies or “Rejected” of Red colour, in case of results not complies.
  • The Passed / released material shall be stored at proper storing condition in the approved Packing Material Store and the Rejected material shall be shifted to the “Rejected Goods Stor

Packing material Issue Note :- The In-charge of Packing Material Store shall make the inventories of the following particulars in this record for the supply of material to the Production Department on the basis of Requisition Slip produced by the Production Department:

  1. Name of the Department to whom issued
  2. Document / Issue No. and Date
  3. Requisition No. and Date
  4. Product to be manufactured, its Batch No, Batch Size, Mfg. date, Exp. Date and Unit Qty.
  5. Name of the material issued, Required Qty., Qty. issued, GRN No., Q.C. No. and Issued Qty.

Packing Material Returned from Production :- In this record, the inventories of following particulars shall be made:

  1. Product Name and its Batch No.
  2. Return Note No. and Date
  3. Production section, Batch Size, Mfg. Month and Exp. Month
  4. Unit Size and Pack Size

Stock Sheet :- In this record the inventories of following particulars shall be made:

    1. Issue No. and Date
    2. Name of item and its A.R. No.
    3. Department to whom issued
    4. Name of product for which issued, its Batch No. and Batch size
    5. Opening balance, Qty. issued and closing balance

Inventory Control regarding Finished Goods :- The following records shall be maintained by the in charge of the Finished Goods Store in which necessary inventories shall be regularly made:

  1. Stock and Sale statement :- In this record the inventories of following particulars shall be made:
  2. No. and Date
  3. Name of product with unit size
  4. Opening stock received from production
  5. Total Qty.
  6. sold
  7. Closing balance

NOTE:-

  •  The inventories in this record shall be made by the finished goods incharge after the receipt of “Daily Production Slip” received from production department and “Release Order” from Quality Assurance department.

Sale Inventory Stock Statement :- In this record the inventories of following particulars shall be made:

  1. No and Date
  2. Product Code, Product Name with Unit size
  • Opening Stock
  1. Opening Stock value
  2. received from Production
  3. sold
  • Closing stock
  • Closing stock value

Sale Invoice :- In this record the inventories of following particulars shall be made:

  1. No. and Date
  2. Name of product, its Unit size, Batch No. and Exp. Date
  • of boxes and Qty. in each box
  1. Total qty.
  2. MRP per unit
  3. Rate per unit
  • Total value
  • Excise duty, Cess on E.D. and Sales tax.
    • The In-charge of stores for Raw Material, Packing Material and Finished Goods shall strictly follow the system of “First In- First Out” to ensure that the oldest approved product or material is used first.
    • The Rejected, Out-dated, Returned / Recalled Finished Goods shall be stored separately from rest of the stocks at the space allocated for this purpose. After clearance from the Managing Director / Executive Director the same shall be destroyed as per SOP titled as “Disposal & Destruction of material” Proper destruction record shall be maintained.
    • The rejected, obsolete or Out-dated raw materials and packing materials shall be stored in a separate room meant for this purpose only and labeled as “Rejected / Out-dated materials” and proper records shall be maintained in this regard separately for Raw Materials and Packing Materials by their store incharges under intimation to Quality Assurance Department.
    • The rejected, returned, recalled, obsolete or outdated raw materials, packing materials and finished goods shall be destroyed as per the procedure laid in the SOP titled “Disposal & Destruction of material”.

Forms and Records (Annexures)

    • Not applicable

Distribution

    • Master copy               –                   Quality Assurance
    • Controlled copies             –                   Quality Assurance, Store, Production

History

For more Pharma posts and updates click Here

 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube